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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024623
Receipt No. R000028329
Scientific Title Examining immune-related molecules for the discovery of potential therapeutic targets in non-small cell lung cancers through the analysis of fresh peripheral blood and/or pleural effusion from patients treated with anti-PD-1 antibodies.
Date of disclosure of the study information 2016/10/31
Last modified on 2019/05/02

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Basic information
Public title Examining immune-related molecules for the discovery of potential therapeutic targets in non-small cell lung cancers through the analysis of fresh peripheral blood and/or pleural effusion from patients treated with anti-PD-1 antibodies.
Acronym Immune-profiling of fresh peripheral blood and/or pleural effusion from non-small cell lung cancer patients treated with anti-PD-1 antibodies.
Scientific Title Examining immune-related molecules for the discovery of potential therapeutic targets in non-small cell lung cancers through the analysis of fresh peripheral blood and/or pleural effusion from patients treated with anti-PD-1 antibodies.
Scientific Title:Acronym Immune-profiling of fresh peripheral blood and/or pleural effusion from non-small cell lung cancer patients treated with anti-PD-1 antibodies.
Region
Japan

Condition
Condition Previously treated patients with non-small cell lung cancer
Classification by specialty
Medicine in general Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To reveal the immune-related molecules involved in the efficiency of anti PD-1 antibodies based on the analysis of fresh peripheral blood and/or pleural effusion.
Basic objectives2 Others
Basic objectives -Others response rate, progression free survival, overall survival
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Immune-profiling of fresh peripheral blood and/or pleural effusion at three time points: pretreatment, post 1st dose, post 2nd dose
Key secondary outcomes Continue to collect blood and/or pleural effusion monthly for analyzing immune profile after discontinuation of anti PD-1 antibody treatment.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Pathologically confirmed non-small-cell lung cancer
2)Stage VI or recurrent diseases (without any indications for operation and radiotherapy) with peripheral blood and/or pleural effusion that can be taken
3)Have measurable lesion in lung by using the RECIST ver1.1 (Response Evaluation Criteria In Solid Tumors) criteria.
4)Twenty or more years old at the time of informed consent
5)Eastern Cooperative Oncology Group Performance Status (ECOG PS)0-2
6)Have adequate organ function within 14 days before entry
7)Estimate life expectancy of at least 12 weeks
8)Have signed an informed consent document
Key exclusion criteria 1)With interstitial pneumonia or pulmonary fibrosis on a chest X-ray
2)Clinically significant drug allergy
3)Presence of other active malignancy
4)With pericardial effusion, pleural effusion and ascites in need of treatment of drainage
5)Positive serum HBs antigen
6)With severe infection, cardiac diseases, diabetes, hypertension, other severe complication
7)Patients received palliative radiotherapy for brain metastases and bone metastases, except for the primary lesion within 2weeks.
8)Pregnancy or lactating patients
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Atsushi
Middle name
Last name Kumanogoh
Organization Osaka University Graduate School of Medicine
Division name Department of Respiratory Medicine, Allergy and Rheumatic Diseases
Zip code 565-0871
Address 2-2 Yamada-oka, Suita, Osaka, 565-0871
TEL 06-6879-3833
Email kumanogo@imed3.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name Shohei
Middle name
Last name Koyama
Organization Osaka University Graduate School of Medicine
Division name Department of Respiratory Medicine, Allergy and Rheumatic Diseases
Zip code 565-0871
Address 2-2 Yamada-oka, Suita, Osaka, 565-0871
TEL 06-6879-3833
Homepage URL
Email koyama@imed3.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization KAKENHI and Funding from non profit foundation

Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Internal Medicine,
Toneyama National Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Medical Center for Translational Research Osaka University Hospital
Address 2-2 Yamada-oka, Suita, Osaka, 565-0871
Tel 0662108290
Email shiken@hp-crc.med.osaka-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 31 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Prospective immune-profiling using fresh whole blood still on going.

In follow-up study after discontinuation of anti-PD-1 treatment, we monitored anti PD-1 antibody binding and immune profiling in T cells until complete loss of residual therapeutic antibody binding. We reported the partial results at IASLC meeting 2017(https://www.sciencedirect.com/science/article/pii/S1556086417329428). We completed the recruitment for the follow-up study May 2017.   
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2016 Year 01 Month 05 Day
Date of IRB
2016 Year 01 Month 05 Day
Anticipated trial start date
2016 Year 10 Month 31 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information In this study, we collect patient samples before and after anti PD-1 antibody treatment and immunologically analyze them without freezing.

Management information
Registered date
2016 Year 10 Month 29 Day
Last modified on
2019 Year 05 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028329

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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